This invention relates generally to tissue localizing devices and methods for their deployment and excision. More particularly, this invention relates to an improved tissue localizing device having the ability to fixedly yet removably bound a tissue volume containing a region of interest, such as a nonpalpable lesion, foreign object, or tumor, preferably but not necessarily without penetrating that tissue volume. This invention also more particularly relates to methods for deploying that device and removing it with an enclosed and intact tissue volume.
Despite the advances made in technologies such as medical imaging to assist the physician in early stage diagnosis and treatment of patients with possible atypical tissue such as cancer, it is still often necessary to sample difficult-to-reliably-reach organ or tissue lesions by biopsy to confirm the presence or absence of abnormalities or disease.
One disease for which biopsy is a critical tool is breast cancer. This affliction is responsible for 18% of all cancer deaths in women and is the leading cause of death among women aged 40 to 55.
In the detection and treatment of breast cancer, there are two general classes of biopsy: the minimally invasive percutaneous biopsy and the more invasive surgical, or xe2x80x9copenxe2x80x9d, biopsy.
Percutaneous biopsies include the use of fine needles or larger diameter core needles. They may be used on palpable lesions or under stereotactic x-ray, ultrasonic, or other guidance techniques for nonpalpable lesions and microcalcifications (which are often precursors to metastatic cell growth). In the fine needle biopsy, a physician inserts a small needle directly into the lesion and obtains a few cells with a syringe. Not only does this technique require multiple samples, but each sample is difficult for the cytologist to analyze as the specimen cells are isolated outside the context of healthy surrounding tissue.
Larger samples may be removed via a core biopsy. This class of procedures is typically performed under stereotactic x-ray guidance in which a needle is inserted into the tissue to drill a core that is removed via vacuum aspiration, etc. Typically four to five samples are taken from the body. Examples of such stereotactic biopsy methods include the MAMMOTOME vacuum aspiration system by Johnson and Johnson of New Brunswick, N.J., the ABBI system by United States Surgical Corporation, Norwalk, Conn., and the SITESELECT system by Imagyn, Inc. of Irvine, Calif.
Open biopsies are advisable when suspicious lumps should be removed in their entirety or when core needle biopsies do not render sufficient information about the nature of the lesion. One such type of open biopsy is the wire localization biopsy.
After multiple mammograms are taken of the breast, the images are analyzed by a computer to determine the location of the suspect lesion in three dimensions. Next, after a local anesthetic is administered, a radiologist inserts a small needle into the breast and passes the needle through the suspect tissue. The radiologist then passes a wire with a hook on its end through the needle and positions the hook so that the end of the wire is distal to the suspect tissue. A final image is taken of the lesion with the accompanying wire in place, and the radiologist marks the film with a grease pencil to indicate the x-ray indicators of a suspicious lesion that should be removed. The wire is left in the tissue and the patient is taken to the operating room, sometimes hours later, where the suspect tissue is removed by a surgeon. The sample is sent to a radiologist to determine, via an x-ray examination, if the sample contains the indicators such as microcalcifications and if the sample size and border are adequate to confirm the removal of all suspicious tissue.
Examples of such wire markers are well known in the art. See, e.g., the following patents, each of which is incorporated herein by reference: U.S. Pat. No. 5,158,084 to Ghiatas, U.S. Pat. No. 5,409,004 to Sloan, U.S. Pat. No. 5,059,197 to Urie et al., U.S. Pat. No. 5,197,482 to Rank, U.S. Pat. No. 5,221,269 to Miller et al., and U.S. Pat. No. 4,592,356 to Gutierrez. Other devices such as that described in U.S. Pat. No. 5,989,265 to Bouquet De La Joliniere et al. and U.S. Pat. No. 5,709,697 to Ratcliff et al., each incorporated herein by reference, are directed to similar devices.
Despite the advantages of wire localization techniques to locate the suspect tissue for the surgeon, they have a number of severe limitations.
Such wires are often inaccurately placed and they cannot be removed except by surgical excision. For these reasons, the radiologist must mark the x-ray film or prepare notations providing instructions to the surgeon on how to find the lesion as a backup to confirm the proper location of the needle.
Because the distal tip of the wire might have been placed anywhere from the very center of the lesion to quite some distance away from the lesion, the surgeon must guide a scalpel along the wire and rely upon the skill of the radiologist and the marked x-ray film in the excision procedure. Even if the wire has been properly placed in the lesion and the x-ray film clearly shows the lesion boundary or margin, the surgeon often cannot see the tip of the wire (given the surrounding tissue) so she must remove a larger portion of tissue than is necessary to ensure proper excision.
If the lesion is not found at the end of the wire, the surgeon ends up cutting or removing non-afflicted tissue without removing the lesion. Also, if the tip of the wire penetrates the lesion, the surgeon may sever the lesion in cutting through the tissue along the wire to reach its end. In the latter case, a re-excision may be necessary to remove the entire lesion. Over twenty-five percent of wire localization procedures require re-excision. Post-excision re-imaging is almost always performed prior to closing the surgical field to ensure that the targeted tissue volume containing the suspect lesion is removed.
When marking lesions in the breast, two paddles are typically used to compress and stabilize the breast for placement of the wire. Upon release of the breast from compression, the wire marker can dislodge or migrate to another position away from the suspect tissue. It may also migrate while the patient awaits surgery. In addition, the fact that the breast is in an uncompressed state for the excision procedure renders a different view of the lesion with respect to the healthy tissue.
Various tissue localization systems have been developed to minimize inadvertent migration of the wire by configuring the wire with a bend or hook, such as Ghiatas et al., discussed above, U.S. Pat. No. 5,011,473 to Gattuma, and the MAMMALOK needle/wire localizer sold by Mitek Surgical Products, Inc., Dedham, Mass. Even if a wire does not migrate after placement, the surgeon cannot determine the shortest path to the lesion; rather, the surgeon must always follow the wire, which is rarely the more cosmetically desirable path to the lesion (such as a circumareolar approach).
Because the distal tip of the wire is often placed in the center of the suspect tissue, a problem known as xe2x80x9ctrack seedingxe2x80x9d can occur in which possible cancerous or precancerous cells are disturbed by the wire and are distributed to unaffected tissue during the procedure.
Aside from the above concerns, the use of a localization wire marker presents logistical problems. After placement, the wire protrudes from the body. It is almost always necessary for the patient to proceed with the surgical removal of the lesion immediately after wire placement to minimize the chance of infection, wire breakage or disturbance, etc. However, delays between placement of the wire and eventual excision often can exceed several hours.
What is needed is a tissue locating device that may be accurately yet removably placed into a region of tissue to surround a volume of tissue that contains a suspect region, preferably without penetrating that volume to disturb it. Such a device should reliably define the border of the volume of tissue to be removed without the risk of self- or inadvertent migration. The device should also provide a surface against which the surgeon may reliably cut when excising the tissue. Furthermore, a need remains to improve the interaction between the radiologist and surgeon, eliminate the need for post-excision x-rays and re-excision, reduce the overall time for the procedure, and allow a surgeon to select the shortest or most cosmetically desirable path to the suspect tissue.
This invention is a tissue localizing device, system, and method for its use.
The tissue localizing device includes a locator element adapted to penetrate tissue so that at least a portion of the locator element defines a tissue border along a first path. This path may include the distalmost portion of the tissue volume. This border in turn defines a volume of tissue for subsequent excision and contains a target region that may be a lesion, foreign object, one or more microcalcifications, or a palpable or nonpalpable mass. This tissue volume is substantially bounded but preferably not penetrated by the locator element. The path the locator element is adapted to follow preferably forms a loop in the tissue having a diameter of at least one centimeter. When deployed, manipulation of a proximal portion of the locator element results in a corresponding direct or proportional manipulation of the tissue volume it bounds. The proximal portion can, but need, not include a tail portion to aid in manipulation.
Preferably the locator element is a partially radiopaque ribbon with one or more optional cutting surfaces. The locator element also preferably exhibits shape memory characteristics. Alternatively, the locator element may be plastically deformed to take an arcuate or curvilinear shape during deployment through a die.
A shoulder portion may be included in the locator element defining a boundary between a preferably more flexible, less rigid proximal portion having a smaller cross-sectional area and a stiffer, more rigid distal portion having a larger cross sectional area compared to that of the proximal portion.
This device may contain a second locator element adapted to penetrate tissue so that at least a portion of it further defines the tissue border along a second path. Again, the target region is substantially bounded but preferably not penetrated by the second locator element. Each of the first and second locator elements may be deployed through a deployment tube having a lumen in which the locator elements are slideably disposed and a distal end through which they may exit into the tissue. The second locator element may be adapted to deploy into the tissue so that it defines a second plane that is not parallel to a first plane defined by the first locator element. These planes may be angularly displaced about a common axis about ninety or forty-five degrees with respect to one another.
The locator elements are adapted to be substantially aligned when deployed with a central axis of the tissue volume they bound or with a tangential axis of that volume.
An optional suture, flexible wire, cable or composite material may be affixed to a proximal end of the locator element to extend through the tissue volume and outside the skin surface when deployed in the body.
This invention is also a tissue localization system which includes a tissue cutting element positionable within a lumen of a driver tube, a trocar positionable within the driver tube lumen, a locator element deployment tube positionable within the driver tube lumen, and at least one locator element positionable within the deployment tube. The cutting element may additionally comprise at least one lumen or tubular member having a distal end disposed along its length.
The locator element is adapted to penetrate tissue so that at least a portion of the locator element defines a tissue border along a first path. The tissue border defines a volume of tissue for subsequent excision along the border, and contains a target region that is substantially bounded by the locator element.
An orientation element also may be attached to the locator element deployment tube, which may be rotatable in fixed angular increments and/or may be infinitely rotatably variable.
A source of energy, such as electrical (RF, etc.), thermal, acoustic, mechanical, or other may be connected to the locator element. The locator element may also be at least partially electrically insulated by a coating of insulative material on one or more sides of the element. This insulative material may have a low coefficient of friction for ease of entry into the tissue if desired.
The locator element deployment tube may comprise a distal end having a locator element cold forming die that may be adapted to plastically deform the locator element into an arcuate shape. The die may include a reverse curve and a positive curve for shaping the locator element, and it may also comprise an axially adjustable upper portion connected to a lower portion.
This invention is also a method for fixedly placing a removable locator element in tissue. This method is accomplished by penetrating through tissue at a first site to create a port or a pathway for accessing a targeted tissue volume to be excised, inserting a deployment tube containing a locator element slideably contained within a lumen of the tube through the port to a position adjacent the targeted tissue volume, and advancing a locator element through a distal end of the tube and penetrating tissue so that at least a portion of the locator element defines a tissue border along a first path. The tissue border will define a volume of tissue for subsequent excision along the tissue border. The tissue volume will contain a target region that is substantially bounded but not penetrated by the locator element.
Alternatively, the invention is a method for excising a volume of tissue that comprises advancing a locator element through tissue to define a tissue border of the volume of tissue to be excised, and cutting tissue substantially along a surface of the locator element opposite a surface of the locator element disposed immediately adjacent the tissue volume.
The locator element may be proximally withdrawn from the tissue after it is advanced to define the tissue border for eventual re-advancement through the distal end of the deployment tube or complete removal from the body.
The locator element may be placed under x-ray guidance, stereotactic x-ray guidance, ultrasonic guidance, magnetic resonance imaging guidance, and the like. Target region visibility may be enhanced by, e.g., the placement or injection of an echogenic substance, such as collagen, hydrogels, microspheres, or other like biocompatible materials, or by the injection of air or other biocompatible gases or contrast agents.
A second and even third or more locator element may also be advanced through the distal end of the deployment tube to penetrate tissue so that at least a portion thereof further defines the tissue border along a second and even third path. The second path and the third path may be non-parallel to the first path occupied by the first locator element, and may be angularly displaced with respect thereto approximately thirty degrees, forty-five degrees, ninety degrees, or at any other angle or angles the radiologist so desires.
This method also includes the step of excising the tissue volume defined by the one or more locator elements. This may be accomplished by surgically accessing the locator element and cutting tissue substantially along a surface of the locator element opposite a surface of the locator element disposed immediately adjacent the tissue volume. Preferably, the device is palpable when in position around the tissue volume. Tissue may be penetrated through any accession path to the tissue volume as the surgeon sees fit. For instance, the surgeon may cut down along the locator element deployment tube, or, when the device is disposed in breast tissue, circumareolarly.
Furthermore, excision may be accomplished or complemented by at least partially energizing the locator element with electrical energy such as RF energy, mechanical energy, thermal energy, vibrational or acoustic energy, and the like. Rotation of the locator element or elements through an angular displacement to facilitate cutting through tissue to remove the tissue volume is contemplated.
This invention also includes a tissue locator element pusher assembly. This pusher assembly includes a housing having a lumen, a pusher slidably disposed in the housing lumen, and a delivery tube affixed to the housing having an optional sharpened distal tip and a tube lumen adapted for slidably receiving the pusher. The pusher may also have a pusher lumen for receiving at least a portion of a tissue locator element. An adjustable fastener for slidably fixing a portion of a tissue locator element to the pusher may also be included.
A deployment fixture may be detachably affixed to a distal end of the housing. The deployment fixture may have at least one fixture lumen axially aligned with the pusher lumen and the delivery tube lumen.
The pusher assembly may also have a tissue locator element having proximal and distal portions that is at least partially disposable in the pusher lumen. A shoulder, which may have at least one tab, may be disposed proximal the locator element distal portion. At least a portion of the tab may extend within or outside a plane defined by the locator element.
This invention is also a tissue locator element pusher assembly that includes a housing having a lumen, a pusher having a pusher lumen slidably disposed in the housing lumen, a tissue locator element at least partially disposed in the pusher lumen, and a delivery tube having an optional sharpened distal tip and affixed to the housing. The delivery tube has a tube lumen adapted for slidably receiving the pusher and the tissue locator element.
A deployment fixture may be detachably affixed to a distal end of the housing. The deployment fixture may have at least one fixture lumen axially aligned with the pusher lumen and the delivery tube lumen. This fixture may also have a second fixture lumen disposed in a plane that is generally orthogonal to a plane in which the first fixture lumen is disposed. An adjustable fastener for slidably fixing a portion of a tissue locator element to the pusher may also be included.
A shoulder, which may have at least one tab, may be disposed proximate the locator element distal portion. At least a portion of the tab may extend within or outside a plane defined by the locator element.
Still further, this invention is a tissue locator element pusher assembly that includes a housing having a proximal end, a distal end, a central housing lumen, and at least one longitudinal slot in communication with the housing lumen, and a pusher slidably disposed in the housing lumen. The pusher has a pusher lumen and an adjustable fastener for slidably fixing a portion of a tissue locator element to the pusher, a control lever affixed to the pusher and extending at least partially through the housing slot, and a tissue locator element at least partially disposed in the pusher lumen. The locator element has a shoulder disposed proximate a distal portion of the locator element.
A delivery tube having a tube lumen adapted for slidably receiving the pusher and the locator element may be disposed on the distal end of the housing in communication with the housing lumen.
Further, this pusher assembly may be configured so that axial movement of the control lever will result in a corresponding axial movement of the pusher and the locator element. In this way, the locator element will reversibly extend through an aperture in a distal end of the delivery tube. The assembly may also be set up so that sufficient axial movement of the control lever may cause it to engage a detent disposed in the housing, prohibiting substantial further axial movement of the control lever. The engagement of the control lever and the detent may be configured to correlate to an extension of the locator element shoulder through the delivery tube distal end aperture. The assembly may further be set up so that just prior to engaging the detent, tactile or other feedback is provided to indicate that the engagement point is about to be reached.
Although the tissue locator element is primarily intended to mark a volume of tissue without penetrating it, the tissue locator element may be used as a tissue localization wire in which at least a portion of a tissue volume (which may or may not include a lesion) is penetrated to mark it for later excision.
When used as a localization device, the wire may be a single- or multiple-piece element adapted to form, upon deployment within tissue of a human patient, a generally straight proximal portion having a longitudinal axis and a curved distal anchoring portion defining a central axis. The central axis should be substantially aligned with the proximal portion longitudinal axis when so deployed. The wire distal anchoring portion may generally assume a curvilinear configuration extending approximately 360 degrees.
Alternatively, when used as a tissue localization device, the unitary or multiple piece wire may be adapted to form, upon deployment within tissue of a human patient, a generally straight proximal portion and a curved distal anchoring portion having a cross-section with a major axis and a minor axis and wherein the major axis is equal to or greater in length than the minor axis. The wire distal anchoring portion may generally assume a curvilinear configuration extending approximately at least 360 degrees. It may further define a central axis that is substantially aligned with the longitudinal axis of the proximal portion.
Still a further tissue localization device is disclosed which consists of a unitary or multiple-piece wire having a shoulder and optional tabs. The wire is adapted to form, upon deployment within tissue of a human patient, a generally straight proximal portion and a curved distal anchoring portion. The wire may have a non-circular cross-section.
The tissue localization device or wire may be combined with other components described herein to form a tissue localization device deployment assembly, which includes a tissue localization wire deployment tube defining a deployment tube lumen, a wire stiffening tube disposable within the deployment tube lumen, and a unitary or multiple-piece tissue localization wire disposable through the stiffening tube lumen. The wire is adapted to form, upon deployment within tissue of a human patient, a generally straight proximal portion and a curved distal anchoring portion having a noncircular cross-section. The wire distal anchoring portion may generally assume a curvilinear configuration extending approximately at least 360 degrees. It may further define a central axis that is substantially aligned with the longitudinal axis of the proximal portion.
The stiffening tube in this assembly defines a stiffening tube lumen and comprises a wire lock, such as a screw reversibly extending through the tube wall, so that the stiffening tube and proximal portion of the wire may be advanced as a single unit into tissue.
An optional shoulder may be disposed on the localization wire, preferably but not necessarily at the junction of the wire proximal and distal portions or proximal to the distal portion. This assembly may also have a deployment tube lumen that is adapted for delivering fluid to the tissue via a hub and port in fluid communication with the tube lumen.
A further alternative tissue localization assembly is within the scope of the invention. This assembly consists of a tissue localization wire deployment tube defining a deployment tube lumen, a wire stiffening tube disposable within the deployment tube lumen, and a tissue localization wire. The wire is adapted to form, upon deployment within tissue such as a lesion, a generally straight proximal portion having a longitudinal axis and a curved distal anchoring portion having a noncircular cross section and a central axis that is substantially aligned with the proximal portion longitudinal axis. The stiffening tube defines a stiffening tube lumen and a wire lock so that the stiffening tube and proximal portion of the wire may be advanced as a single unit into tissue.